December 18, 2020
Three-phase human trials of the first made-in-Vietnam Covid-19 vaccine is scheduled to complete in February 2022 after commencing Thursday.
Human trials of Nanocovax, the first Covid-19 vaccine in Vietnam developed by Nanogen Pharmaceutical Biotechnology JSC, began Thursday morning with two men and a woman in their 20s getting shots at Vietnam Military Medical University in Hanoi.
The vaccine trial will ultimately consist of three phases.
Nanogen said it would complete the first phase in February next year in Hanoi, testing the vaccine with a group of 60 volunteers in collaboration with Vietnam Military Medical University.
For this phase, volunteers 18-50 years of age are divided into three random groups to receive three doses of 25 mcg, 50 mcg, and 75 mcg of the vaccine or a placebo. The vaccination consists of a two-dose schedule 28 days apart.
The second phase is scheduled to start within February next year and last until August, with 400-600 volunteers aged 12-75 vaccinated. Aside from Vietnam Military Medical University, Nanogen will coordinate with the National Institute of Hygiene and Epidemiology and HCMC Pasteur Institute during this phase.
The final phase will last until February 2022, with 1,500-3,000 volunteers aged from 12 to 75 injected with the vaccine in either India, Indonesia, or Bangladesh.
For now, the Ministry of Health has established three delegations to inspect, monitor, and assist the Covid-19 vaccine research team at Nanogen.
The first three volunteers who received the 25-mcg dose on Thursday are healthy after one day. They will stay at the Vietnam Military Medical University to be monitored for 72 hours after the vaccination, and then receive daily health check for six months.
The remaining 57 volunteers participating in the first phase are scheduled to be vaccinated next Tuesday.
Nguyen Ngo Quang, deputy head of the ministry’s Administration of Science, Technology and Training, said the first phase is the most important because it can tell whether the vaccine is safe for humans.
It is tested on a small group of volunteers so that in case it causes any calamities, those in charge could intervene more rapidly and effectively.
Nanogen has bought insurance cover for all volunteers and inked deals with some banks to pay compensation totaling VND20 billion ($863,290) should the insurer default.
Vietnam currently has four Covid vaccines under development, the other three by the Institute of Vaccines and Medical Biologicals (IVAC), Vaccine and Biological Production Company No. 1 (Vabiotech), and the Center for Research and Production of Vaccines and Biologicals (Polyvac).
The vaccines developed by IVAC and Vabiotech are expected to enter human trials in early 2021. Vietnam also has plans to import Covid-19 vaccines.
Globally, 11 vaccines have entered phase three clinical trials to date.